Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors (DOTATATENET)
Primary Purpose
Gastro-Entero-Pancreatic Tumors (GEPs)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET-CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastro-Entero-Pancreatic Tumors (GEPs)
Eligibility Criteria
Inclusion Criteria:
• Age ≥ 18,
- Patient with one of the following situations : suspicion of GEP, initial staging of non-metastatic GEP, GEP with unknown primary tumor, Restaging of GEP justifying focused therapeutic approach
- Reference imaging within the last 3 months: multiphasic thoracoabdominal CT scan, liver MRI and SRS (SPECT/CT).
Exclusion Criteria:
- Pregnant or breast-feeding woman
- Other cancer disease
- GEP with grade 3 tumours
- Non GEP TNE (paragangliome, medullar thyroid cancer)
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
assesment by 68Ga-DOTATATE PET-CT
Arm Description
Outcomes
Primary Outcome Measures
interest of the realization of 68Ga-DOTATATE PET-CT in the detection of tumor sites in TNE diagnosis, staging and restaging
Secondary Outcome Measures
therapeutic impact of 68Ga-DOTATATE PET-CT in addition to reference imaging (SRS, CT, MRI): we will document the rate of changes in treatment options induced by PET-CT
Full Information
NCT ID
NCT02150408
First Posted
May 26, 2014
Last Updated
April 5, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02150408
Brief Title
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors
Acronym
DOTATATENET
Official Title
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 22, 2014 (Actual)
Primary Completion Date
May 24, 2017 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs.
Historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy.
The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS. Furthermore, patient irradiation and imaging protocol are significantly reduced.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Entero-Pancreatic Tumors (GEPs)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
assesment by 68Ga-DOTATATE PET-CT
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
PET-CT
Primary Outcome Measure Information:
Title
interest of the realization of 68Ga-DOTATATE PET-CT in the detection of tumor sites in TNE diagnosis, staging and restaging
Time Frame
12-15 months
Secondary Outcome Measure Information:
Title
therapeutic impact of 68Ga-DOTATATE PET-CT in addition to reference imaging (SRS, CT, MRI): we will document the rate of changes in treatment options induced by PET-CT
Time Frame
12-15 months
Other Pre-specified Outcome Measures:
Title
therapeutic impact of 68Ga-DOTATATE PET-CT in addition to reference imaging (SRS, CT, MRI): we will document the rate of changes in treatment options induced by PET-CT
Time Frame
12-15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Age ≥ 18,
Patient with one of the following situations : suspicion of GEP, initial staging of non-metastatic GEP, GEP with unknown primary tumor, Restaging of GEP justifying focused therapeutic approach
Reference imaging within the last 3 months: multiphasic thoracoabdominal CT scan, liver MRI and SRS (SPECT/CT).
Exclusion Criteria:
Pregnant or breast-feeding woman
Other cancer disease
GEP with grade 3 tumours
Non GEP TNE (paragangliome, medullar thyroid cancer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David TAIEB, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors
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